CN102362863A - Orlistat-containing preparation and preparation method thereof - Google Patents
Orlistat-containing preparation and preparation method thereof Download PDFInfo
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- CN102362863A CN102362863A CN2011103706592A CN201110370659A CN102362863A CN 102362863 A CN102362863 A CN 102362863A CN 2011103706592 A CN2011103706592 A CN 2011103706592A CN 201110370659 A CN201110370659 A CN 201110370659A CN 102362863 A CN102362863 A CN 102362863A
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Abstract
The invention relates to an Orlistat-containing preparation and a preparation method thereof. The preparation contains an Orlistat coating layer, and is prepared after forming the Orlistat coating layer by coating surface of a blank tablet or blank pill with molten Orlistat. When the preparation method provided by the invention is used to prepare the Orlistat preparation, the sticking and picking problem aroused by melting of Orlistat in a production process can be effectively solved, and at the same time, the preparation retains high stability and dissolution rate.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of preparation that contains orlistat and preparation method thereof.
Background technology
The chemical name of orlistat: N-formyl-L-leucine (s)-1 [(2s, 3s) 3-hexyl-4 oxygen base-2-glycidyl methyl] ten diester, also claim tetrahydrochysene lipstatin (THL), be a kind of semisynthetic lipstatin derivant, structural formula is following:
Orlistat is the crystallinity powder of a kind of white to off-white color, is a kind of liposoluble substance, and the dissolubility in the water of physiological pH is very low; Be a kind of lipase inhibitor, because it has lower fusing point, about 44 ℃; Can be because of hydrolysis or hot the degraded; Particularly be stored in malaria or the humid air more than 65 ℃, it is all anti-in external to have various lipases such as a lipoprotein lipase, the activity of the synzyme of pancreas triglycerides lipase and fatty acid; Make from triglyceride in the diet and can not be hydrolyzed into the FFA that be prone to absorb, thereby it is not absorbed and excretes external.
The Alli of the prescription drugs Xenical that contains principal agent 120mg that the present slimming medicine that with the orlistat is main active is gone on the market is Luo Shi and the nonprescription drugs that contains principal agent 60mg of GlaxoSmithKline PLC.
US6004996 discloses a kind of method for preparing of orlistat preparation; Be active component to be prepared in the hard capsules of packing into behind the piller form, the active component comprising 50%, adjuvant mainly be as diluent with extrude round as a ball microcrystalline Cellulose; Make the sodium lauryl sulphate of solubilizing agent; As the 30 POVIDONE K 30 BP/USP 30 of binding agent and the Pulvis Talci that is used as lubricant, be prepared into the 0.25-2mm piller with extruder, the hard capsules of packing into then.But find in the test: if piller hardness is big, then the medicine stripping is relatively poor; If piller hardness is little, frangible in the capsule charge process, heat production during production in enormous quantities causes piller surface orlistat to melt, and then the sticking bar, makes to produce to be difficult to carry out smoothly.
W02009050720 discloses the pharmaceutical composition of the water-soluble polymer carrier of a kind of stable orlistat that contains 20-60% and 40-80%; Water-solubility carrier is selected from hydroxypropyl methylcellulose, methylcellulose, hydroxypropyl cellulose; Increase the dissolution of orlistat, improved the bioavailability of orlistat.Adopt fluid unit, the preparation process is following:
(a) preparation contains the aqueous solution of the water soluble polymer material of surfactant.
(b) the orlistat powder is dispersed in this solution.
(c) the orlistat suspension is sprayed on pharmaceutically acceptable pharmaceutic adjuvant surface, is processed into dosage form at last.
But; This suspension is sprayed in the process on graininess adjuvant surface; Orlistat raw material surface that can not be all will inevitably be attached at particulate outer surface by some orlistat all by polymer overmold, equally can be because of drift heating sticking in the tabletting process.Because the employing solvent is a water, and baking temperature is low again, dry run is longer simultaneously.
US7393545 discloses a kind of plain sheet of soluble fiber of lipase inhibitor, has adopted a large amount of methylcellulose as carrier, causes sheet heavy very big; Increased patient's medication difficulty; If take after dissolving, mouthfeel is bad again, does not fundamentally solve sticking problem in the tabletting process; Just weigh, reduced the content of orlistat through increasing sheet.
Summary of the invention
Deficiency in view of prior art the objective of the invention is to further investigate through physicochemical properties and preparation thereof to orlistat, and a kind of novel orlistat preparation and preparation method thereof is provided.The orlistat preparation that the present invention is prepared efficiently solves the sticking problem that causes because of the orlistat thawing in the production process, and preparation has kept stability and dissolution preferably simultaneously.
The objective of the invention is to realize like this:
A kind of preparation that contains orlistat contains the orlistat coatings, and described preparation is through with the orlistat fused solution, and coating is prepared from after blank or blank piller surface form described orlistat coatings.
The described preparation that contains orlistat, wherein said blank or blank piller comprise filler, disintegrating agent and lubricant.
The described preparation that contains orlistat, wherein said blank or blank piller comprise filler, disintegrating agent, binding agent and lubricant.
The described preparation that contains orlistat, wherein said filler are selected from following one or more: starch, lactose, Icing Sugar, mannitol, dextrin, cyclodextrin, microcrystalline Cellulose and sucrose; Described disintegrating agent is selected from following one or more: carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, pregelatinized Starch and low-substituted hydroxypropyl cellulose; Described lubricant is selected from following one or more: magnesium stearate, Pulvis Talci and micropowder silica gel.
The described preparation that contains orlistat, wherein said orlistat coatings is surrounded by the gastric solubleness film-coat outward.
A kind of method for preparing of orlistat preparation may further comprise the steps:
(1) after the heating orlistat becomes oily, keep the fused solution temperature between 40-60 ℃;
(2) with the orlistat fused solution blank or piller are carried out coating.
A kind of method for preparing of orlistat preparation; The heating orlistat makes thawing, through coating, orlistat is wrapped in piller or sheet sub-surface; Because do not add entry or organic solvent; When the coating temperature was lower than 40 ℃, orlistat just can solidify and attached to slice, thin piece or piller surface, so the coating process need not heating.
Preferably, the method for preparing of described orlistat preparation wherein adopts the gastric solubleness coating solution to carry out coating again.
Compared with prior art, orlistat preparation that the present invention relates to and preparation method thereof has following advantage and obvious improvement:
(1) a kind of orlistat preparation of the present invention has been avoided because orlistat is crossed the unfavorable factor in the low preparation process that causes because of fusing point, can be prepared into various dosage forms pharmaceutically commonly used.
(2) tablet, piller can directly be packed behind the coating of the present invention; Perhaps continue bag film-coat on the surface; Preventing that piller surface orlistat from filling out in the process friction and melt dashing, so the present invention efficiently solves the thawing of orlistat in the production process and the sticking problem that causes.
(3) a kind of orlistat preparation of the present invention because orlistat is evenly distributed on dosage surface, helps the quick stripping of orlistat in gastrointestinal tract body fluid.In addition, the orlistat stability of formulation is good.
(4) a kind of orlistat preparation of the present invention, its preparation process is fairly simple, easy to operate, is fit to industrialized great production.
The specific embodiment
Further describe beneficial effect of the present invention through following examples at present; Embodiment only is used for the purpose of illustration; Do not limit the scope of the invention, conspicuous change and modification that while those of ordinary skills are made according to the present invention are also contained within the scope of the invention.
Embodiment 1 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, lactose, carboxymethyl starch sodium, magnesium stearate mix homogeneously, tabletting gets blank;
50 ℃ of heat fused of orlistat with fused solution coating on blank, promptly get.
Embodiment 2 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, starch, carboxymethyl starch sodium, magnesium stearate mix homogeneously, tabletting gets blank;
45 ℃ of heat fused of orlistat with fused solution coating on blank, obtain containing tablet;
To contain tablet bag gastric solubleness clothing, promptly get.
Embodiment 3 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, starch, carboxymethyl starch sodium, magnesium stearate mix homogeneously, it is an amount of to add 2% 30 POVIDONE K 30 BP/USP, 30 aqueous solutions, granulate, tabletting, blank;
60 ℃ of heat fused of orlistat with fused solution coating on blank, obtain containing tablet;
To contain tablet bag gastric solubleness clothing, promptly get.
Embodiment 4 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, carboxymethyl starch sodium mix homogeneously, it is an amount of to add 2% 30 POVIDONE K 30 BP/USP, 30 aqueous solutions, extrusion granulator is round as a ball, blank piller;
50 ℃ of heat fused of orlistat with fused solution coating on blank piller, obtain the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, promptly get.
Embodiment 5 (10000)
Starch piller 3000g
Orlistat 1200g
Gastric solubleness coating solution weightening finish 2%
Preparation technology:
60 ℃ of heat fused of orlistat with fused solution coating on the starch piller, obtain the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, promptly get.
Embodiment 6 (10000)
Microcrystalline Cellulose piller 4000g
Orlistat 1200g
Gastric solubleness coating solution weightening finish 2%
Preparation technology:
55 ℃ of heat fused of orlistat with fused solution coating on the microcrystalline Cellulose piller, obtain the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, promptly get.
Embodiment 7 (10000)
Sucrose piller 4000g
Orlistat 1200g
Gastric solubleness coating solution weightening finish 2%
Preparation technology:
60 ℃ of heat fused of orlistat with fused solution coating on the sucrose piller, obtain the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, promptly get.
Comparative example 1 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, lactose, carboxymethyl starch sodium, orlistat, magnesium stearate mix homogeneously, tabletting promptly gets.
Comparative example 2 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, lactose, carboxymethyl starch sodium, orlistat, magnesium stearate mix homogeneously, tabletting promptly gets.
Comparative example 3 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, carboxymethyl starch sodium, orlistat mix homogeneously, it is an amount of to add 2% 30 POVIDONE K 30 BP/USP, 30 aqueous solutions, extrusion granulator, round as a ball, drying obtains the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, promptly get.
Comparative example 4 (10000)
Preparation technology:
Recipe quantity microcrystalline Cellulose, carboxymethyl starch sodium, orlistat mix homogeneously, it is an amount of to add entry, and extrusion granulator is round as a ball, and drying obtains the pastille piller;
With pastille piller bag gastric solubleness clothing, incapsulate, promptly get.
Comparative example 5 (10000)
Sucrose piller 4000g
Orlistat 1200g
Preparation technology:
60 ℃ of heat fused of orlistat with fused solution coating on the sucrose piller, obtain the pastille piller;
With the pastille piller, incapsulate, promptly get.
Embodiment 8 orlistat stability of formulation and dissolution determinations
Dissolution is got these article, according to dissolution method (two appendix XC second methods of Chinese Pharmacopoeia version in 2010), (gets sodium lauryl sulphate 30g and sodium chloride 5g with the pH6.0 buffer; Adding water 1000ml dissolving, and regulate pH value to 6.0 with phosphoric acid) 1000ml is dissolution medium, rotating speed is that per minute 75 changes; Operation in accordance with the law, in the time of 45 minutes, it is an amount of to get solution; Filter, get subsequent filtrate as need testing solution; It is an amount of that other gets the orlistat reference substance, and accurate the title decides, and adds acetonitrile and make dissolving in right amount, quantitatively dilutes with dissolution medium and process the solution that contains 0.12mg among every 1ml approximately, as reference substance solution.According to the chromatographic condition under the assay item, precision is measured need testing solution and each 20 μ l of reference substance solution, injects chromatograph of liquid respectively, the record chromatogram.By the stripping quantity of external standard method with every of calculated by peak area.Limit is 75% of a labelled amount, should be up to specification.
Related substance is got these article fine powder an amount of (being equivalent to orlistat 25mg approximately), accurately claims surely, puts in the 50ml measuring bottle, adds the mobile phase ultrasonic dissolution and is diluted to scale, shakes up, and puts in the glass centrifuge tube centrifugally, gets supernatant as need testing solution; Precision is measured 1ml, puts in the 100ml measuring bottle, adds mobile phase and is diluted to scale, shakes up, as contrast solution.According to the chromatographic condition under the assay item, get contrast solution 20 μ l and inject chromatograph of liquid, regulate detection sensitivity, the peak height that makes the main constituent chromatographic peak is 10%～20% of a full scale.Precision is measured each 20 μ l of need testing solution and contrast solution again, injects chromatograph of liquid respectively, 5 times of record chromatogram to main constituent peak retention time.If any impurity peaks (deduction adjuvant peak), single impurity peak area must not be greater than 0.2 times (0.2%) of contrast solution main peak peak area in the chromatogram of need testing solution, each impurity peak area with must not be greater than 3 times (3.0%) of contrast solution main peak peak area.
The orlistat stability of formulation and the dissolution of each embodiment preparation of table 1
| Visual examination | Related substance (single assorted) | Dissolution | |
| Embodiment 1 | The off-white color sheet is unilateral bright and clean | Related substance 0.12% | 94.2-99.1％ |
| Embodiment 2 | The off-white color sheet is unilateral bright and clean | Related substance 0.13% | 94.5-98.2％ |
| Embodiment 3 | The off-white color sheet is unilateral bright and clean | Related substance 0.14% | 92.3-97.8％ |
| Embodiment 4 | The off-white color piller, smooth surface | Related substance 0.12% | 94.5-95.2％ |
| Embodiment 5 | The off-white color piller, smooth surface | Related substance 0.12% | 93.4-99.2％ |
| Embodiment 6 | The off-white color piller, smooth surface | Related substance 0.13% | 94.5-95.2％ |
| Embodiment 7 | The off-white color piller, smooth surface | Related substance 0.14% | 95.5-98.7％ |
| The comparative example 1 | The off-white color sheet, sticking, unilateral have a piebaldism | Related substance 0.12% | 81.2-86.7％ |
| The comparative example 2 | The off-white color sheet, sticking, unilateral have a piebaldism | Related substance 0.13% | 82.7-88.8％ |
| The comparative example 3 | The off-white color piller has melting phenomenon | Related substance 0.12% | 83.6-90.5％ |
| The comparative example 4 | The off-white color piller has melting phenomenon | Related substance 0.14% | 80.5-85.6％ |
| The comparative example 5 | The off-white color piller has melting phenomenon | Related substance 0.14% | 95.5-98.7％ |
Find out from comparing result: the orlistat preparation of embodiment of the invention 1-3 preparation is unilateral smooth, embodiment 4-7 piller smooth surface, and related substance is less, and stripping is complete;
Comparative example 1-4, although related substance is little, dissolution is relatively poor, and the orlistat of comparative example 1-2 preparation is unilateral that piebaldism arranged, sticking, there is melting phenomenon on comparative example 3-4 orlistat piller surface;
The comparative example 5, though related substance is little, stripping is complete, and there is melting phenomenon on the piller surface.
This shows that the prepared tablet of the present invention is unilateral bright and clean, the piller smooth surface, stripping is rapid, has compared with prior art obtained significant technique effect.
Claims (8)
1. preparation that contains orlistat is characterized in that: contain the orlistat coatings, described preparation is through with the orlistat fused solution, and coating is prepared from after blank or blank piller surface form described orlistat coatings.
2. the preparation that contains orlistat according to claim 1 is characterized in that: described blank or blank piller comprise filler, disintegrating agent and lubricant.
3. the preparation that contains orlistat according to claim 1 is characterized in that: described blank or blank piller comprise filler, disintegrating agent, binding agent and lubricant.
4. according to claim 2 or the 3 described preparations that contain orlistat, it is characterized in that: described filler is selected from following one or more: starch, lactose, Icing Sugar, mannitol, dextrin, cyclodextrin, microcrystalline Cellulose and sucrose; Described disintegrating agent is selected from following one or more: carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula sodium, pregelatinized Starch and low-substituted hydroxypropyl cellulose; Described lubricant is selected from following one or more: magnesium stearate, Pulvis Talci and micropowder silica gel.
5. according to each described preparation that contains orlistat of claim 1-3, it is characterized in that: described orlistat coatings is surrounded by the gastric solubleness film-coat outward.
6. the preparation that contains orlistat according to claim 4 is characterized in that: described orlistat coatings is surrounded by the gastric solubleness film-coat outward.
7. the method for preparing of an orlistat preparation may further comprise the steps:
(1) after the heating orlistat becomes oily, keep the fused solution temperature between 40-60 ℃;
(2) with the orlistat fused solution blank or piller are carried out coating.
8. the method for preparing of orlistat preparation according to claim 7 is characterized in that: adopt the gastric solubleness coating solution to carry out coating.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103393608A (en) * | 2013-08-13 | 2013-11-20 | 杭州高成生物营养技术有限公司 | Cetilistat pellet and preparation method thereof |
| CN106727398A (en) * | 2017-02-21 | 2017-05-31 | 鲁南制药集团股份有限公司 | A kind of simvastatin tablet |
| CN106822020A (en) * | 2017-02-21 | 2017-06-13 | 鲁南制药集团股份有限公司 | A kind of Ezetimibe tablet |
| CN106983723A (en) * | 2017-05-08 | 2017-07-28 | 重庆植恩药业有限公司 | Orlistat liposome and preparation method thereof and the application in antineoplastic |
| CN111297826A (en) * | 2020-04-20 | 2020-06-19 | 鲁南制药集团股份有限公司 | Stable orlistat capsule and preparation method thereof |
| CN114767634A (en) * | 2022-03-14 | 2022-07-22 | 大邦(湖南)生物制药有限公司 | Orlistat pellet, preparation method thereof and orlistat capsule |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103393608A (en) * | 2013-08-13 | 2013-11-20 | 杭州高成生物营养技术有限公司 | Cetilistat pellet and preparation method thereof |
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| CN106822020A (en) * | 2017-02-21 | 2017-06-13 | 鲁南制药集团股份有限公司 | A kind of Ezetimibe tablet |
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| CN106983723B (en) * | 2017-05-08 | 2018-08-21 | 重庆植恩药业有限公司 | Orlistat liposome and preparation method thereof and the application in antitumor drug |
| CN111297826A (en) * | 2020-04-20 | 2020-06-19 | 鲁南制药集团股份有限公司 | Stable orlistat capsule and preparation method thereof |
| CN111297826B (en) * | 2020-04-20 | 2021-08-03 | 鲁南制药集团股份有限公司 | Stable orlistat capsule and preparation method thereof |
| CN114767634A (en) * | 2022-03-14 | 2022-07-22 | 大邦(湖南)生物制药有限公司 | Orlistat pellet, preparation method thereof and orlistat capsule |
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| CN102362863B (en) | 2013-06-12 |
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Inventor after: Zhang Guimin Inventor after: Zhao Zhiquan Inventor after: Hao Guizhou Inventor after: Feng Zhong Inventor before: Zhao Zhiquan Inventor before: Hao Guizhou Inventor before: Feng Zhong |
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Free format text: CORRECT: INVENTOR; FROM: ZHAO ZHIQUAN HAO GUIZHOU FENG ZHONG TO: ZHANG GUIMIN ZHAO ZHIQUAN HAO GUIZHOU FENG ZHONG |